Otrexup, Otrexup Pfs

Manages severe, active rheumatoid arthritis (RA) and … idiopathic arthritis (pJIA). NDA 204824, held by Cosette. Methotrexate.

As of Nov 13, 2026, NDA 204824 (Otrexup, Otrexup Pfs), held by Cosette, was first approved by FDA on Oct 11, 2013, with 9 approved supplements and 0 published complete response letters.

First approved: Oct 11, 2013
Review: Standard
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Otrexup is a folate analog metabolic inhibitor indicated for the:

Management of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy.
Symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy. Limitation of Use Otrexup is not indicated for the treatment of neoplastic diseases. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below


Oct 11, 2013	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter
Oct 11, 2013	Original applicationEfficacy (new indication or use) · Standard review	Approved	Review Label Letter

Products

14 strengths and forms


Otrexup10MG/0.4ML (10MG/0.4ML) · solution;subcutaneous	Methotrexate	DiscontinuedReference drug
Otrexup15MG/0.4ML (15MG/0.4ML) · solution;subcutaneous	Methotrexate	DiscontinuedReference drug
Otrexup20MG/0.4ML (20MG/0.4ML) · solution;subcutaneous	Methotrexate	DiscontinuedReference drug
Otrexup25MG/0.4ML (25MG/0.4ML) · solution;subcutaneous	Methotrexate	DiscontinuedReference drug
Otrexup7.5MG/0.4ML (7.5MG/0.4ML) · solution;subcutaneous	Methotrexate	DiscontinuedReference drug
Otrexup12.5MG/0.4ML (12.5MG/0.4ML) · solution;subcutaneous	Methotrexate	DiscontinuedReference drug
Otrexup17.5MG/0.4ML (17.5MG/0.4ML) · solution;subcutaneous	Methotrexate	DiscontinuedReference drug
Otrexup22.5MG/0.4ML (22.5MG/0.4ML) · solution;subcutaneous	Methotrexate	DiscontinuedReference drug
Otrexup Pfs10MG/0.4ML (10MG/0.4ML) · solution;subcutaneous	Methotrexate	DiscontinuedReference drug
Otrexup Pfs15MG/0.6ML (15MG/0.6ML) · solution;subcutaneous	Methotrexate	DiscontinuedReference drug
Otrexup Pfs17.5MG/0.7ML (17.5MG/0.7ML) · solution;subcutaneous	Methotrexate	DiscontinuedReference drug
Otrexup Pfs20MG/0.8ML (20MG/0.8ML) · solution;subcutaneous	Methotrexate	DiscontinuedReference drug
Otrexup Pfs22.5MG/0.9ML (22.5MG/0.9ML) · solution;subcutaneous	Methotrexate	DiscontinuedReference drug
Otrexup Pfs25MG/ML (25MG/ML) · solution;subcutaneous	Methotrexate	DiscontinuedReference drug

All 11 submissions, including labeling and manufacturing supplements


Dec 26, 2019	Supplement 10Labeling · Standard review	Approved	Label Letter
Jun 19, 2019	Supplement 9Labeling · Standard review	Approved	Label Letter
Mar 15, 2018	Supplement 8Labeling · Standard review	Approved	Letter Label
May 31, 2017	Supplement 6Manufacturing · Standard review	Approved	Label
Jan 11, 2017	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 24, 2016	Supplement 4Manufacturing · Standard review	Approved	Label
Nov 7, 2014	Supplement 3Manufacturing · Standard review	Approved	Letter Label
Oct 8, 2014	Supplement 2Manufacturing · Standard review	Approved	None posted
Oct 7, 2014	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 11, 2013	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter
Oct 11, 2013	Original applicationEfficacy (new indication or use) · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 204824
Drugs@FDA: Overview at FDA
Company: Cosette

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters